Primary Device ID | EKUR000967KA0 |
NIH Device Record Key | b5847946-2728-430a-bb89-477579b8ba8b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Disposable brush tips (black) |
Version Model Number | #967-KA |
Company DUNS | 697119498 |
Company Name | KURARAY NORITAKE DENTAL INC. |
Device Count | 50 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | EKUR000967KA0 [Unit of Use] |
HIBCC | EKUR000967KA1 [Primary] |
KXR | Applicator, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-09-01 |
Device Publish Date | 2025-08-22 |
EKUR000967KA0 - Disposable brush tips (black) | 2025-09-01 |
EKUR000967KA0 - Disposable brush tips (black) | 2025-09-01 |
EKUR000968KA0 - Disposable brush tips (white) | 2025-09-01 |
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